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Soo Park, MD
Soo Park, MD
Posted: Wednesday, August 14, 2024
According to Xiaoting Wei, MD, of Peking University Cancer Hospital and Institute, Beijing, and colleagues, the investigational MEK inhibitor tunlametinib (also known as HL-085) has demonstrated anticancer activity in a phase II Chinese study of patients with NRAS-mutant melanoma. During the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9545), these investigators presented the results from an updated efficacy analysis of this clinical trial (ClinicalTrials.gov identifier NCT05217303).
“Tunlametinib demonstrated an encouraging treatment response rate in patients with advanced NRAS-mutant melanoma with a manageable safety profile,” the investigators concluded. “These results suggest that tunlametinib could be a promising treatment option for NRAS-mutant melanoma, even for those who had previously received immunotherapy.”
This single-arm, multicenter trial treated 95 patients with NRAS-mutant, unresectable, stage III or IV melanoma with 12 mg of oral tunlametinib twice daily. Study endpoints included objective response rate, progression-free survival, and overall survival.
The median follow-up was 24.4 months, and the confirmed objective response rate was 35.8%. The median progression-free survival and overall survival were 4.2 and 13.7 months, respectively. When stratified by melanoma subtype, objective response rates were 42.9% in those with acral melanoma and 25.0% in patients with mucosal melanoma; rates stratified by NRAS mutation site were 41.3% for Q61, 20.0% for G13, and 13.3% for G12.
Of note, the objective response rate among patients who received prior immunotherapy was higher than that of those who had not (40.6% vs 25.8%). Furthermore, the difference in progression-free survival was not statistically significant across subgroups, regardless of NRAS mutation site, type or number of previous treatments, use of immunotherapy, and melanoma type.
The safety profile of tunlametinib was consistent with previous results. The most common treatment-related adverse events were diarrhea, peripheral and facial edema, increased blood creatinine phosphokinase, and increased aspartate aminotransferase; no treatment-related deaths were reported.
Disclosure: Dr. Wei reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.
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